WEDNESDAY, July 24, 2002 (HealthDayNews) -- Up to now, implanted jump-starters of the heart called defibrillators have been used only in patients revived after suffering cardiac arrest, or for patients at high risk of going into arrest.
But the U.S. Food and Drug Administration has now made as many as 4 million more Americans eligible for the device by authorizing its use in heart attack survivors whose hearts don't pump effectively. The FDA made the change after Guidant Corp., the defibrillators' manufacturer, proved in a clinical trial of 1,200 heart attack survivors that the devices reduced their chances of dying by one-third.
About 220,000 Americans die each year from cardiac arrest, which occurs when the electrical signals that pump the heart malfunction.
An implanted cardioverter defibrillator (ICD), like the one used by Vice President Dick Cheney, constantly monitors the recipient's heartbeat and automatically jolts the heart to restore its rhythm in case of cardiac arrest.
In widening use of the device, the FDA also ruled that the new candidates don't need to undergo a once-routine invasive test where doctors run a catheter inside the heart to trigger an irregular heartbeat.
Here is the FDA Talk Paper describing the agency's recent ruling on the expanded use of ICDs.
